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CHMP reverses on Ninlaro, also backs Lartruvo, Ibrance

September 16, 2016 7:00 AM UTC

EMA's CHMP recommended approval of three cancer medicines on Friday, including a reversal of opinion for multiple myeloma (MM) drug Ninlaro ixazomib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502).

The committee recommended conditional approval of Ninlaro in combination with Revlimid lenalidomide and dexamethasone to treat relapsed or refractory MM in adults who have received at least one prior therapy. In June, Takeda requested that the committee re-examine a negative recommendation in which CHMP had concluded that the oral proteasome inhibitor's possible benefit was insufficient to outweigh its risks. On Friday, CHMP said it concluded that the benefits outweigh the risks, citing expert opinions, progression-free survival (PFS) data and a favorable safety profile. ...